Overview
- 14 public-safe observations are available for this inspection.
- 7 structured CFR citations are represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
24 Apr 2024
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Edmund F Mrak, Bijoy Panicker
24 Apr 2024
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Edmund F Mrak, Bijoy Panicker
24 Apr 2024
21 CFR 211.142(b)
Storage under appropriate conditions
Cited by Edmund F Mrak, Bijoy Panicker
Inspected site
ARAmerican Regent, Inc.Shirley, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.142(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10)(iii) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 2x |
Source document
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PDF available
Form 483 source document
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Full 483 report
Get the verbatim text of all 14 observations
The source PDF, so your team sees exactly what was cited and how it was answered.
- The site's full inspection history around this Form 483
- Whether these citations escalated to a warning letter
- The investigators involved and the citations they repeat elsewhere